Acupressure and Stress Resilience

NCT01614444 | Completed

• 1 other identifier: COMIRB# 12-0452
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The current study will assess the efficacy of acupressure, a type of complementary and alternative medicine (CAM) in the Veteran population. Veterans with co-occurring mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) will be consented and randomly assigned to either an active or placebo acupressure treatment series of 8 sessions. The investigators will determine if acupressure affects aspects of day-to-day function, such as memory, sleep, mood, psychiatric health and stress resilience. This information will help identify potential treatment strategies to improve quality of life and overall function in this particular Veteran population.

Conditions

Post-traumatic Stress Disorder (PTSD); Mild Traumatic Brain Injury (mTBI)

Outcome Measures

Primary Outcomes (1)

• Trier Social Stress Test

  72 hours post final acupressure treatment

Study Arms (2)

Acupressure Treatment

ACTIVE COMPARATOR

Other: Active Acupressure Treatment

Placebo Acupressure Treatment

PLACEBO COMPARATOR

Other: Placebo Acupressure Treatment

Interventions

Active Acupressure Treatment OTHER

Participant will receive 8 active acupressure treatments.

Acupressure Treatment

Placebo Acupressure Treatment OTHER

Participants will receive 8 placebo acupressure treatments.

Placebo Acupressure Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18-60
• Diagnosis of mild TBI and PTSD as assessed by interview and/or chart review
• Currently receiving or eligible to receive physical and/or mental healthcare through the VA Eastern Colorado Health Care System

You may not qualify if:

• History of other significant neurological disease (e.g., Alzheimer's, Parkinson's, multiple sclerosis etc.) as assessed by interview and/or chart review. Such conditions could affect outcome measures independently, thereby creating an experimental confound.
• History or diagnosis of lifetime moderate to severe TBI, as assessed by interview and/or chart review.
• History of psychotic disorder or bipolar I disorder as assessed by structured interview. Such conditions could affect outcome measures independently, thereby creating an experimental confound.
• Inability to read the informed consent document or adequately respond to questions regarding the informed consent procedure.
• Prior experience with acupressure, as this would result in individuals potentially being able to detect Placebo treatments if randomly assigned to that group.

Sponsors & Collaborators

• VA Eastern Colorado Health Care System: lead
• University of Colorado, Boulder: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Denver VAMC

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Theresa D Hernandez, Ph.D.

  Senior Investigator and Research Psychologist Eastern Colorado Healthcare System, VISN19, MIRECC

  PRINCIPAL INVESTIGATOR

• Lisa A Brenner, Ph.D.

  Eastern Colorado Healthcare System VISN 19 MIRECC Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of MIRECC (Mental Illness Research, Education and Clinical Center

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 8, 2012
• Study Start: June 13, 2012
• Primary Completion: August 11, 2014
• Study Completion: March 7, 2017
• Last Updated: May 19, 2017

Record last verified: 2017-05

Locations

US (1)